System and Method for Automated Dosage Calculation and Patient Treatment Life Cycle for a Transgender Patient

ABSTRACT

A computer-implemented method of providing a dosage and a transgender patient treatment lifecycle comprising receiving, by a computerized device, an input signal of a user indicating an input directed to a patient sex and a patient status, wherein the patient status is automatically determined by the processor and includes at least one of a new patient, a returning patient and a booster patient, determining by the processor at least one of an effective estradiol dosage and an effective testosterone dosage using dosage calculation methods selected based on the patient status, automated male-to-female input parameters or automated female-to-male input parameters, and male-to-female or female-to-male tracking parameters in response to receiving an input indicating that the patient sex is male-to-female or female-to-male, displaying on the display screen, the determined effective dosages, and administering a pellet comprising at least one of the determined effective dosages to the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. application Ser. No.16/799,820 filed Feb. 24, 2020 entitled “SYSTEM AND METHOD FOR AUTOMATEDDOSAGE CALCULATION AND PATIENT TREATMENT LIFE CYCLE” which is acontinuation of U.S. application Ser. No. 15/125,529 filed Mar. 11, 2015and issued on Feb. 25, 2020 as U.S. Pat. No. 10,572,628 entitled “SYSTEMAND METHOD FOR AUTOMATED DOSAGE CALCULATION AND PATIENT TREATMENT LIFECYCLE” which claims priority to U.S. Provisional Patent Application Ser.No. 61/951,415 filed on Mar. 11, 2014, and entitled “SYSTEM AND METHODFOR AUTOMATED DOSAGE CALCULATION AND PATIENT TREATMENT LIFE CYCLE.”

BACKGROUND 1. Field of the Invention

The present invention relates to systems and methods for providing atreatment to a patient, for example, providing and monitoring hormonetherapy. More particularly, the invention relates to systems and methodsfor automating a patient treatment lifecycle and a recommended dosagefor a transgender patient with respect to hormone therapy.

2. Description of Related Art

Hormone replacement therapy includes estradiol and testosterone forfemales and testosterone for males. Data supports that hormonereplacement therapy with pellet implants is more effective and a morebio-identical method to deliver hormones in both men and women. Not onlydo pellet implants deliver a biologically identical hormone, the pelletimplants deliver the hormones in the proper human ratio. Pellet implantsare made up of either estradiol or testosterone and are placed under theskin to deliver consistent, healthy levels of hormones for 3-5 months inwomen and 4-6 months in men. Pellet implants deliver hormones directlyinto the blood stream, and the release of hormones from pellets isdependent on heart rate and cardiac output (i.e., the rate of hormonerelease is controlled through the action of the cardiovascular system).Thus, pellet implants result in hormone delivery that nearlyapproximates what the human gonad can do. In addition, pellet implantscan inhibit the fluctuations, or ups and downs, of hormone levels seenwith other conventional methods of hormone delivery.

Estrogen delivered by subcutaneous pellets, maintains the normal ratioof estradiol to estrone. This is important for optimal health anddisease prevention. Pellets do not increase the risk of blood clots likeconventional or synthetic hormone replacement therapy. In both men andwomen, testosterone has been shown to increase energy, relievedepression, increase sense of wellbeing, relieve anxiety, and improvememory and concentration. Testosterone, delivered by pellet implant,increases lean body mass (muscle strength, bone density) and decreasesfat mass. Men and women need adequate levels of testosterone for optimalmental and physical health and for the prevention of chronic illnesseslike Alzheimer's and Parkinson's disease and heart attacks, which areassociated with low testosterone levels.

For male-to-female (MTF) and female-to-male (FTM) transitioningpatients, hormone therapy using subcutaneous pellets for delivery ofestrogen and testosterone can be used for relieving gender dysphoria.Estrogen and testosterone are both used for feminizing therapy whichinduces feminine physical characteristics for MTF transitioning patientsto relieve gender dysphoria. Testosterone is used for masculinizingtherapy, which induces masculine physical characteristics for FTMtransitioning patients to similarly relieve gender dysphoria.

The insertion of pellets is a relatively painless procedure done underlocal anesthesia. The pellets are usually inserted in the lowerabdominal wall or upper buttocks through a small incision, which is thentaped closed. The experience of the health care professional matters agreat deal, not only in placing the pellets, but also in determining thecorrect dosage of hormones to be used.

Traditionally, determination of recommended dosage for hormone therapyrequires that a physician consider numerous factors, including patientage, weight, height, health conditions, contraindications, hormonallevels, previous and current medications, and the like. In all, a properdetermination involves correct consideration and weighing of manyfactors, some of which the physician may not even have easy access to,such as a patient's detailed health record.

However, even if the patient's detailed health record is accessible,many hormone therapy practices require the physician to re-enter datarelated to the patient to track and/or calculate the proper dosage. Thisis time consuming and often results in erroneous data entered into inputfields of a dosage monitoring system. This can result in inaccuratedosing, which for transitioning patients can delay the feminizing ormasculinizing process, prolonging gender dysphoria, and resulting inother potential health consequences.

SUMMARY

The present invention overcomes the aforementioned drawbacks byproviding a system and method that automatically calculates an accuraterecommended dosage for hormone therapy and automates the life cycle ofthe patient's treatment by accurately calculating follow-up hormonedoses when used in conjunction with proper lab tests. In particular thepresent invention calculates the dosage of hormones such as testosteroneand estradiol to effectuate a patient's desired gender transition whileminimizing potential side effects.

In one aspect of the present invention, a computer-implemented method ofproviding a dosage and a transgender patient treatment lifecycle isprovided. The method includes receiving, by a computerized deviceincluding a processor, an input device, and a display screen, an inputsignal of a user indicating an input directed to a patient sex and apatient status. The patient status is automatically determined by theprocessor and includes a status from the group of a new patient, areturning patient and a booster patient. When inputting male-to-femaletransitioning patients the processor determines an effective estradioldosage and an effective testosterone dosage using dosage calculationmethods selected based on the patient status, automated male-to-femaleinput parameters, and male-to-female tracking parameters. When inputtingfemale-to-male transitioning patients the processor determines aneffective testosterone dosage using dosage calculation methods selectedbased on the patient status, automated female-to-male input parameters,and female-to-male tracking parameters. The determined effective dosagesare displayed on the screen, and a physician administers a pellet basedon the effective dosages displayed.

The input parameters may include physical activity level, quantity ofpatient visits, patient age, patient height, weight, race, number ofpregnancies, number of live births, number of abortions, history ofrenal disease, history of active liver disease, hysterectomy, history ofcervical cancer, history of ovarian cancer, history of fibrocysticbreast disease, history of breast cancer, current follicle stimulatinghormone (FSH) level, current testosterone level, current estradiollevel, history of acne, history of facial hair, history of hair loss,history of prostate cancer, history of polycystic ovary syndrome (PCOS),history of hysterectomy, history of heavy menses, history of metabolicsyndrome, history of venous thrombotic events, history ofestrogen-sensitive neoplasm, end-stage chronic liver disease, tobaccouse, unstable coronary artery disease, untreated polycythemia,hematocrit level, cardiovascular disease, cerebrovascular disease, bonedensity, aggression, development of feminine characteristics, anddevelopment of masculine characteristics. The processor may furtherautomatically calculate, the patient age based on a date of birthentered into the input device and the patient height based on a heightparameter entered into the input device by the user.

The dosage method for a male-to-female booster and return patient mayalso include the processor receiving lab results on patient levels ofestradiol, total testosterone, free testosterone, and prostate-specificantigen (PSA). The processor may then determines an estradiol dosage inresponse to receiving an indication that the level of estradiol of thepatient that is between approximately 200 and 400 pg/ml. Depending onthe levels of total testosterone, free testosterone, and PSA theprocessor may also calculate an anti-androgen dosage. The dosage methodfor a female-to-male booster and return patient may also include theprocessor receiving lab results on patient levels of estradiol, totalestrogens, total testosterone, and free testosterone. The processor maycalculate a testosterone dosage in response to receiving an indicationthat the level of total testosterone is between approximately 600 and800 ng/dl. The processor may further determine the dosage of eitherletrozole dosage or anastrozole dosage based on the level of estradioland the level of total estrogens.

The method for calculating effective dosages may also be based on inputparameters such as physical activity level, quantity of patient visits,patient age, patient height, weight, race, number of pregnancies, numberof live births, number of abortions, history of renal disease, historyof active liver disease, hysterectomy, history of cervical cancer,history of ovarian cancer, history of fibrocystic breast disease,history of breast cancer, current follicle stimulating hormone (FSH)level, current testosterone level, current estradiol level, history ofacne, history of facial hair, history of hair loss, history of prostatecancer, history of polycystic ovary syndrome (PCOS), history ofhysterectomy, history of heavy menses, history of metabolic syndrome,history of venous thrombotic events, history of estrogen-sensitiveneoplasm, end-stage chronic liver disease, tobacco use, unstablecoronary artery disease, untreated polycythemia, hematocrit level,cardiovascular disease, cerebrovascular disease, bone density,aggression, development of feminine characteristics, and development ofmasculine characteristics.

In some cases, the display may show the patient's past insertionhistory, including previous insertion date, previous testosterone dose,previous estradiol dose, pellet insertion location, and pellet insertionside. The processor may also identify an insertion time frame for returndosing for returning and booster patients based on the past insertionhistory. The display shows the previous insertion date, the previoustestosterone dose, the previous estradiol dose, the pellet insertionlocation, and the pellet insertion side at the time of pellet insertion.The user may identify a new pellet insertion location based on any ofthe pellet insertion location, the previous insertion date, the previoustestosterone dose and the previous estradiol dose described in the inthe past insertion history. Using the dosage calculation method selectedbased on the male-to-female tracking parameters and the female-to-maletracking parameters may include tracking any of a pellet insertionlocation, a pellet insertion side, a pellet dose, a pellet lot number,an insertion note, a previous testosterone dose, and a previousestradiol dose.

The method for dosage calculation may include automatically displayingat least one of the previous estradiol dose and the previoustestosterone dose on the display screen of the input device, wherein theprevious estradiol dose and the previous testosterone dose are based ona last full dosage, the last full dosage being different from at leastone previous effective dosage. Tracking the pellet insertion locationand the pellet insertion side can be based on historical insertioninformation including at locations such as a hip location, an abdominallocation, a left side, and a right side. The historical insertioninformation may also provide a basis for the processor to automaticallysuggest the pellet insertion location and the pellet insertion side. Theprocessor may also provide an option for the user to manually inputeither the pellet insertion location or the pellet insertion side, theat least one of the pellet insertion location and the pellet insertionside being different from the pellet insertion location and the pelletinsertion side automatically suggested by the processor. Further, thepellet lot number may be tracked by entering one or more correspondinglot numbers into a lot number field provided on the display screen ofthe input device.

The method for dosage calculation may also include the processorcalculating the size of an estradiol pellet and a testosterone pelletcorresponding to the effective dosage for estradiol and testosteroneaccording to an algorithm. The algorithm minimizes the size of thepellet while maintaining an effective dose. The display may furtherprovide an option to the user to manually input the size of theestradiol pellet and the testosterone. It also allows a user to manuallyinput the size of the estradiol or testosterone pellet outside of thesize determined by the algorithm. The algorithm may further operate byusing the processor to order a plurality of pellet sizes from largest tosmallest and subtract the largest pellet size from the effective dosage.If the result of the subtraction is greater than zero then the processorassigns the largest pellet size as the estradiol or testosterone pelletsize for insertion. If the result is less than zero, the processorsubtracts the effective dosage from the next smallest pellet size andrepeats until the result is greater than zero. The processor calculatesthe absolute value of the results and assigns the estradiol ortestosterone pellet resulting in a lesser absolute value for insertion.

The method for dosage calculation may further include showing on thedisplay an estradiol pellet size insertion corresponding to theeffective estradiol dosage and a testosterone pellet size insertioncorresponding to the effective testosterone dosage. The input device mayalso receive another input signal from the user indicating an increaseor a decrease the estradiol pellet size insertion or the testosteronepellet size insertion. The processor calculates in real-time, an updatedeffective estradiol dosage and an updated effective testosterone dosagebased on the input signal of the user. The dosage may further becalculated by incorporating a return visit associated with the patientto determine the effective estradiol dosage and the effectivetestosterone dosage.

The method may further include providing a comprehensive toolkit on theinput device, the comprehensive toolkit kit may include an ancillarysupport function, a patient consult request, a patient consult response,an article, a video, a form, news, an update, a product purchase order,a financial report, and an assistant assignment related to the dosageand patient treatment life-cycle. The method may also include theprocessor tracking a profitability metric for the patient and generatinga report corresponding to the profitability metric over time.

Another aspect of the present invention is a computer-implemented methodof providing a dosage and a transgender patient treatment life-cycle.The method includes receiving, by a computerized device including aprocessor, an input device, and a display screen, an input signal of auser indicating an input directed to a patient gender identity and apatient status. The patient status is automatically determined by theprocessor and may be a new patient, returning patient, or a boosterpatient. The processor determines the effective dosage of estradiol ortestosterone using a calculation method based on the patient status,automated input parameters, and tracking parameters. The processorfurther uses a pellet allocation algorithm to determine the size ofpellet for estradiol or testosterone corresponding to an effective doseof estradiol or testosterone. The pellet allocation algorithm minimizesthe size of pellet for insertion. The display shows the effectivedosages, the estradiol pellet size, and the testosterone pellet size. Auser may then administer a pellet containing one of the effectivedosages to the patient. The processor further determines the effectiveestradiol dosage and the effective testosterone dosage if the patientgender identity is male-to-female. For a patient gender identity offemale-to-male the processor determines the effective testosteronedosage.

The automated input parameters of the method include one from the groupof physical activity level, quantity of patient visits, patient age,patient height, weight, race, number of pregnancies, number of livebirths, number of abortions, history of renal disease, history of activeliver disease, hysterectomy, history of cervical cancer, history ofovarian cancer, history of fibrocystic breast disease, history of breastcancer, current follicle stimulating hormone (FSH) level, currenttestosterone level, current estradiol level, history of acne, history offacial hair, history of hair loss, history of prostate cancer, historyof polycystic ovary syndrome (PCOS), history of hysterectomy, history ofheavy menses, history of metabolic syndrome, history of venousthrombotic events, history of estrogen-sensitive neoplasm, end-stagechronic liver disease, tobacco use, unstable coronary artery disease,untreated polycythemia, hematocrit level, cardiovascular disease,cerebrovascular disease, bone density, aggression development offeminine characteristics, and development of masculine characteristics.The processor may automatically calculate the patient's age based on adate of birth entered into the input device by the user and the patientheight based on a height parameter entered into the input device by theuser.

The dosage method for a male-to-female booster and return patient mayfurther include the processor receiving the level of estradiol, totaltestosterone, free testosterone, and PSA of the patient. The processordetermines an estradiol dosage in response to the level of estradiolbeing between approximately 200 and 400 pg/ml. The processor may furtherdetermine an anti-androgen dosage based on the levels of totaltestosterone, free testosterone, and PSA. For a female-to-male boosterand return patient, the dosage method includes the processor receivingthe levels of estradiol, total estrogens, total testosterone, and freetestosterone of the patient. When the processor receives an indicationthat level of total testosterone is between approximately 600 and 800ng/dl, it determines a testosterone dosage. The processor furthercalculates a dosage of letrozole or anastrozole based on the levels ofestradiol and total estrogens.

The method further includes selecting a dosage calculation based on thetracking parameters including tracking a pellet insertion location, apellet insertion side, a pellet dose, a pellet lot number, an insertionnote, a previous testosterone dose, and a previous estradiol dose. Thedisplay may also automatically show the previous estradiol dose and theprevious testosterone dose on the display screen, the previous estradioldose and the previous testosterone dose being based on a last fulldosage. In some cases, the last full dosage is different from theprevious effective dosage.

The method for dosage calculation may also include the processorcalculating the size of an estradiol pellet and a testosterone pelletcorresponding to the effective dosage for estradiol and testosteroneaccording to an algorithm. The algorithm minimizes the size of thepellet while maintaining an effective dose. The display may furtherprovide an option to the user to manually input the size of theestradiol pellet and the testosterone. It also allows a user to manuallyinput the size of the estradiol or testosterone pellet outside of thesize determined by the algorithm. The algorithm may further operate byusing the processor to order a plurality of pellet sizes from largest tosmallest and subtract the largest pellet size from the effective dosage.If the result of the subtraction is greater than zero then the processorassigns the largest pellet size as the estradiol or testosterone pelletsize for insertion. If the result is less than zero, the processorsubtracts the effective dosage from the next smallest pellet size andrepeats until the result is greater than zero. The processor calculatesthe absolute value of the results and assigns the estradiol ortestosterone pellet resulting in a lesser absolute value for insertion.

The dosage calculation may further include incorporating at least onereturn visit associated with the patient to determine the effectiveestradiol dosage and the effective testosterone dosage.

The method may further include providing a comprehensive toolkit on theinput device, the comprehensive toolkit kit may include an ancillarysupport function, a patient consult request, a patient consult response,an article, a video, a form, news, an update, a product purchase order,a financial report, and an assistant assignment related to the dosageand patient treatment life-cycle. The method may also include theprocessor tracking a profitability metric for the patient and generatinga report corresponding to the profitability metric over time.

Aspects and applications of the invention presented here are describedbelow in the drawings and detailed description of the invention. Unlessspecifically noted, it is intended that the words and phrases in thespecification and the claims be given their plain, ordinary, andaccustomed meaning to those of ordinary skill in the applicable arts.The inventors are fully aware that they can be their own lexicographerif desired. The inventors expressly elect, as their own lexicographers,to use only the plain and ordinary meaning of terms in the specificationand claims unless they clearly state otherwise and then further,expressly set forth the “special” definition of that term and explainshow it differs from the plain and ordinary meaning. Absent such clearstatements of intent to apply a “special” definition, it is theinventors' intent and desire that the simple, plain and ordinary meaningto the terms be applied to the interpretation of the specification andclaims.

The inventor is also aware of the normal precepts of English grammar.Thus, if a noun, term, or phrase is intended to be furthercharacterized, specified, or narrowed in some way, then such noun, term,or phrase will expressly include additional adjectives, descriptiveterms, or other modifiers in accordance with the normal precepts ofEnglish grammar. Absent the use of such adjectives, descriptive terms,or modifiers, it is the intent that such nouns, terms, or phrases begiven their plain, and ordinary English meaning to those skilled in theapplicable arts as set forth above.

Further, the inventor is fully informed of the standards and applicationof the special provisions of 35 U.S.C. § 112(f). Thus, the use of thewords “function,” “means” or “step” in the Detailed Description orDescription of the Drawings or Claims is not intended to somehowindicate a desire to invoke the special provisions of 35 U.S.C. §112(f), to define the invention. To the contrary, if the provisions of35 U.S.C. § 112(f) are sought to be invoked to define the inventions,the claims will specifically and expressly state the exact phrases“means for” or “step for, and will also recite the word “function”(i.e., will state “means for performing the function of [insertfunction]”), without also reciting in such phrases any structure,material or act in support of the function. Thus, even when the claimsrecite a “means for performing the function of . . . ” or “step forperforming the function of . . . ,” if the claims also recite anystructure, material or acts in support of that means or step, or thatperform the recited function, then it is the clear intention of theinventor not to invoke the provisions of 35 U.S.C. § 112(f). Moreover,even if the provisions of 35 U.S.C. § 112(f) are invoked to define theclaimed inventions, it is intended that the inventions not be limitedonly to the specific structure, material or acts that are described inthe preferred embodiments, but in addition, include any and allstructures, materials or acts that perform the claimed function asdescribed in alternative embodiments or forms of the invention, or thatare well known present or later-developed, equivalent structures,material or acts for performing the claimed function.

The foregoing and other aspects, features, and advantages will beapparent to those artisans of ordinary skill in the art from theDETAILED DESCRIPTION, DRAWINGS, and CLAIMS.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the detailed description when considered in connection withthe following illustrative figures. In the figures, like referencenumbers refer to like elements or acts throughout the figures.

FIG. 1 is a schematic system diagram of an exemplary system configuredto implement the present invention.

FIG. 2 is a block diagram of an exemplary communication deviceconfigured to be implemented into the system of FIG. 1.

FIG. 3 is a block diagram of an exemplary server configured to beimplemented into the system of FIG. 1.

FIG. 4 is a flow chart setting forth the steps of processes fordetermining a dosage for hormone replacement therapy for a femalepatient in accordance with the present invention.

FIG. 5 is a flow chart setting forth the steps of processes fordetermining a dosage for hormone replacement therapy for a male patientin accordance with the present invention.

FIG. 6 is a flow chart setting forth the steps of processes forautomatically calculating an accurate recommended dosage for hormonereplacement therapy and automating a life cycle of a patient's treatmentover time in accordance with another aspect of the present invention.

FIG. 7 is an exemplary screen shot of a user interface of thecommunication device that prompts a user to select a patient type.

FIG. 8 is an exemplary screen shot of a new patient dialog screendisplayed on the user interface.

FIG. 9 is an exemplary screen shot of a patient list displayed on theuser interface.

FIG. 10 is an exemplary screen shot of a patient list displayed on theuser interface that may be presented to the user after searching for anexisting patient.

FIG. 11 is an exemplary screen shot of an existing patient dialog screendisplayed on the user interface.

FIG. 12 is an exemplary screen shot of a dosing calculation page thatmay be displayed to the user on the user interface once patientinformation has been entered or selected.

FIG. 13 is an exemplary screen shot of a prescribe patient dialog screendisplayed on the user interface.

FIG. 14 is an exemplary screen shot of a patient information dialogscreen including the patient's insertion history displayed on the userinterface of the communication device.

FIG. 15 is an exemplary screen shot of the prescribe patient dialogscreen of FIG. 13 showing lot numbers of pellets inserted into thepatient.

FIG. 16 is an exemplary screen shot of a search screen for searching lotnumbers corresponding to the patient.

FIG. 17 is an exemplary screen shot of a patient consult request form tobe filled with information about the patient.

FIG. 18 is an exemplary screen shot of a patient consults screen showinga list of consult requests awaiting response from the user.

FIG. 19 is an exemplary screen shot of an individual patient consultscreen after selecting the patient consult request from the list ofconsult requests of FIG. 18.

FIG. 20 is an exemplary screen shot of a patient consult requests statusscreen.

FIG. 21 is an exemplary screen shot of a patient consult response screenshowing relevant patient parameters and a recommended course of action.

FIG. 22 is an exemplary screen shot of a news videos and updates screenshowing links to news videos and updates related to hormone replacementtherapy.

FIG. 23 is an exemplary screen shot of a knowledge base articles searchscreen for searching through relevant articles on hormone replacementtherapy.

FIG. 24 is an exemplary screen shot of a products screen showingavailable products for the patient to purchase.

FIG. 25 is an exemplary screen shot of a pellet calendar for assigningfinancial numbers to patient prescriptions.

FIG. 26 is an exemplary screen shot of a daily pellet list for enteringfinancial information related to a patient visit.

FIG. 27 is an exemplary screen shot of a patient bill widow showingcheckout amounts to be attached to the patient visit of FIG. 26.

FIG. 28 is an exemplary screen shot of an end of day report screenshowing a full financial view of a hormone replacement therapy practice.

FIG. 29 is an exemplary screen shot of a prescription summary reportscreen showing patient and gender counts and revenues and dosing feesper provider.

FIG. 30 is a schematic diagram of an organization structure configuredto be implemented into the system of FIG. 1.

FIG. 31 is an exemplary screen shot of a provider screen providing aprovider record to specify an office.

FIG. 32 is an exemplary screen shot of an assistant login screen that islinked to a provider.

FIG. 33 is a flow chart setting forth the steps of processes fordetermining a dosage for hormone therapy for a female-to-male (FTM)transitioning patient in accordance with the present invention.

FIG. 34 is a flow chart setting forth the steps of processes fordetermining a dosage for hormone therapy for a male-to-female (MTF)transitioning patient in accordance with the present invention.

Elements and acts in the figures are illustrated for simplicity and havenot necessarily been rendered according to any particular sequence orembodiment.

DETAILED DESCRIPTION

In the following description, and for the purposes of explanation,numerous specific details are set forth in order to provide a thoroughunderstanding of the various aspects of the invention. It will beunderstood, however, by those skilled in the relevant arts, that thepresent invention may be practiced without these specific details. Inother instances, known structures and devices are shown or discussedmore generally in order to avoid obscuring the invention. In many cases,a description of the operation is sufficient to enable one to implementthe various forms of the invention, particularly when the operation isto be implemented in software. It should be noted that there are manydifferent and alternative configurations, devices and technologies towhich the disclosed inventions may be applied. The full scope of theinventions is not limited to the examples that are described below.

Referring now to FIG. 1, a system 100, such as a dosage monitoringsystem, is shown that is configured to determine a recommended dosagefor hormone replacement therapy and automate the life cycle of thepatient's treatment over time. The system 100 may include, but is notlimited to, a communication device 102, a network 104, a user interface(UI) presentation server 108, an application server 106, a cache server112, and a database 114. Also depicted is a physician user 110, forillustrative purposes. In one exemplary embodiment, the functionality ofthe UI presentation server 108, application server 106, and cache server112 may be combined into one or two servers without affecting theefficacy of the system 100. Also, servers 106, 108 and 112 may includeidentical components or may differ in composition, and are describedgenerically herein as “server 106, 108, 112”.

The UI presentation server 108 may provide the user interface to thecommunication device 102 over the network 104. The network 104 may be alocal or wide, wired or wireless, network including, for example, theInternet. Data input through the communication device 102 may beforwarded to the application server 106 for processing and/or storage inthe database 114. The database 114 may be accessible by the server 106,108, 112 and may store data regarding the patient, patient test results,prior dosing information, prior side effects, and any other medicallysignificant information. The server 106, 108, 112 may access thedatabase 114 for information and may also store information therein. Thecache server 112 may save frequently-used data for fast access asneeded. The database 114 may be a stand-alone database server, apersistent drive, and operating software associated with the applicationserver 106, a cloud-computing database “cloud”, or may be implemented byother means. The communication device 102 is configured to communicatewith the UI presentation server 108 over the network 104 to send andobtain data regarding a patient. The patient data can include, but isnot limited to, information needed for enabling the determination ofrecommended dosages for hormone replacement therapy.

Referring now to FIG. 2, there is provided a more detailed block diagramof the communication device 102. The communication device 102 may be,but is not limited to, a mobile phone, a smart phone, a PDA, a tabletPersonal Computer (“PC”), or the like. Notably, the communication device102 can include more or less components than those shown in FIG. 2. Forexample, the communication device 102 may include a wired systeminterface, such as a universal serial bus interface (not shown in FIG.2). The communication device 102 may further include an antenna 202 forreceiving and transmitting Radio Frequency (RF) signals, for example. Areceive/transmit (Rx/Tx) switch 204 may selectively couple the antenna202 to a transmitter circuitry 206 and a receiver circuitry 208.

The receiver circuitry 208 may be configured to demodulate and decodethe RF signals received from a network (e.g., the network 104 of FIG. 1)to derive information therefrom. The receiver circuitry 208 is coupledto a controller 210 via an electrical connection 234. The receivercircuitry 208 may provide the decoded RF signal information to thecontroller 210. The controller 210 uses the decoded RF signalinformation in accordance with the function(s) of the communicationdevice 102. The controller 210 also provides information to thetransmitter circuitry 206 for encoding and modulating information intoRF signals. Accordingly, the controller 210 is coupled to thetransmitter circuitry 206 via an electrical connection 238. Thetransmitter circuitry 206 may communicate the RF signals to the antenna202 for transmission to an external device (e.g., network equipment ofnetwork 104 of FIG. 1).

The controller 210 may store the decoded RF signal information in amemory 212 of the communication device 102. Accordingly, the memory 212is connected to and accessible by the controller 210 through anelectrical connection 232. The memory 212 can be a volatile memoryand/or a non-volatile memory. For example, the memory 212 can include,but is not limited to, a Random Access Memory (RAM), a Dynamic RandomAccess Memory (DRAM), a Static Random Access Memory (SRAM), Read-OnlyMemory (ROM), and flash memory. The memory 212 may also have storedtherein software applications 252 and user-defined rules 254. Thesoftware applications 252 may include, but are not limited to,applications operative to provide telephone services, networkcommunication services, Internet connectivity and access services,commerce services, email services, web based services, and/or electroniccalendar services.

As shown in FIG. 2, one or more sets of instructions 250 may also bestored in the memory 212. The instructions 250 can also reside,completely or at least partially, within the controller 210 duringexecution thereof by the communication device 102 of FIG. 1. In thisregard, the memory 212 and the controller 210 can constitutenon-transient machine-readable media. The term “machine-readable media”,as used here, refers to a single medium or multiple media that store theone or more sets of instructions 250. The term “machine-readable media”,as used here, also refers to any medium that is capable of storing,encoding or carrying the set of instructions 250 for execution by thecommunication device 102 and that cause the communication device 102 toperform one or more of the methodologies of the present disclosure.

The controller 210 is also connected to a user interface 230. The userinterface 230 may include input devices 216, output devices 224, andsoftware routines (not shown in FIG. 2) configured for a user tointeract with and control the software applications 252 installed on thecommunication device 102. Such input and output devices respectivelyinclude, but are not limited to, a display 228, a speaker 226, a keypad220, a directional pad (not shown in FIG. 2), a directional knob (notshown in FIG. 2), a microphone 222, a Push-To-Talk (“PTT”) button 218,sensors 240, a camera 242, and a Radio Frequency Identification (“RFID”)reader 244.

Referring now to FIG. 3, there is provided a more detailed block diagramof the server 106, 108, 112 of FIG. 1. While FIG. 3 illustrates atraditional server architecture, it is noted that other configurationsmay also be used. For example, some or all of the hardware or softwaremay be distributed among multiple servers. Likewise, functionality maybe distributed across or incorporate the use of communications networksincluding the Internet. To this end, parts or all of the hardware andsoftware described herein may represent so-called “cloud” computingsolutions. As another non-limiting example, the user interface may bedistributed across multiple devices, including servers, mobile devices,non-mobile computing devices, and the like. Likewise, software may berun as a dedicated application, distributed across remote servers and/orserved from the “cloud”, run in a browser, or be embodied in a mobileapplication.

The server 106, 108, 112 may include a system interface 322, a userinterface 302, a Central Processing Unit (CPU) 306, a system bus 310, amemory 312 connected to and accessible by other portions of the server106, 108, 112 through the system bus 310, and hardware entities 314connected to the system bus 310. At least some of the hardware entities314 perform actions involving access to and use of the memory 312, whichcan be a Random Access Memory (RAM), a disk driver and/or a Compact DiscRead Only Memory (CD-ROM). Some or all of the listed components 302-322can be implemented as hardware, software and/or a combination ofhardware and software. The hardware includes, but is not limited to, anelectronic circuit.

The server 106, 108, 112 may include more, less or different componentsthan those illustrated in FIG. 3. The hardware architecture of FIG. 3represents one embodiment of a representative server configured toprovide supporting services to a user of a communication device (e.g.,communication device 102 of FIG. 1). For example, the server 106, 108,112 may implement a method for lookup of available auctions using anexternal database in communication with the server 106, 108, 112(database not depicted), or the server may use its existing disk driveunit 316, computer-readable storage medium 318 and other facilities tostore auction information, as needed. It may also provide dosage factordata to the communication device 102, as needed. Exemplary embodimentsof said method will be described below in relation to FIGS. 4-5.

Hardware entities 314 can include microprocessors, Application SpecificIntegrated Circuits (ASICs) and other hardware. Hardware entities 314can include a microprocessor programmed for facilitating the provisionof the automatic software function control services to a user of thecommunication device (e.g., communication device 102 of FIG. 1). In thisregard, it should be understood that the microprocessor can access andrun various software applications (not shown in FIG. 3) installed on theserver 106, 108, 112. Such software applications include, but are notlimited to, database applications.

As shown in FIG. 3, the hardware entities 314 can include a disk driveunit 316 comprising a computer-readable storage medium 318 on which isstored one or more sets of instructions 320 (e.g., software code or codesections) configured to implement one or more of the methodologies,procedures, or functions described herein. The instructions 320 can alsoreside, completely or at least partially, within the memory 312 and/orwithin the CPU 306 during execution thereof by the server 108. Thememory 312 and the CPU 306 also can constitute machine-readable media.The term “machine-readable media”, as used here, refers to a singlemedium or multiple media (e.g., a centralized or distributed database,and/or associated caches and servers) that store the one or more sets ofinstructions 320. The term “machine-readable media”, as used here, alsorefers to any medium that is capable of storing, encoding or carrying aset of instructions 320 for execution by the server 106, 108, 112 andthat cause the server 106, 108, 112 to perform any one or more of themethodologies of the present disclosure.

Referring now to FIGS. 4-5, flow charts setting forth exemplary steps400, 500 for determining a dosage for hormone replacement therapy areprovided. Exemplary embodiments of the disclosure are presented in FIGS.4-5 with respect to methods for calculating hormone replacement therapy(HRT) dosage, in particular for calculation of SOTTOPELLE™ HRT dosage.References to “HRT” in the descriptions to FIGS. 4-5 herein areunderstood to specifically refer to SOTTOPELLE™ HRT, unless otherwiseindicated. It is understood that the tables, lookup values, factors usedin these embodiments may vary depending on several variables, such asbut not limited to therapy regimens, drug used, drug concentration,absorption, efficacy, and the like.

Although use of a communication device 102, as described in FIG. 2, ispresented herein, the present disclosure is not limited in this regard.The methods are useful with alternative devices as well, such asportable computer applications, PDA applications, and tablet computingdevices, and the like. The exemplary steps 400, 500 described in FIGS.4-5 may be performed by an electronic circuit of the communicationdevice 102, with the assistance of the physician 110, servers 106, 108,112, database 114 and network 104, consistent with an embodiment of thedisclosure.

Returning to FIG. 4, to start the process for determining the dosage fora female patient, a patient type is identified at decision block 402.The patient type may be determined by the electronic circuit, aspreviously described with respect to FIG. 3. Additionally, oralternatively, the physician 110 of FIG. 1 may manually input thepatient type directly into the communication device 102 or, the patienttype may be determined from the patient name and/or a uniqueidentification number combined with a lookup of patient informationstored in the database 114. The patient types identified at block 402may include: A Female New Patient, as shown at process block 403, whichmay be a female patient that has never been treated with HRT or someonewho has not received pellets for over ten months; A Female ReturnPatient, as shown at process block 404, which may be a female patientthat has been treated with HRT and is returning for ongoing treatment;Or a Female Booster Patient, as shown at process block 405, which may bea female patient that has been treated with HRT needing an additionaldose prior to the patient's next dose.

Once the patient type is identified, input parameters may be input intothe communication device, regardless of which patient type isidentified, at process block 406. The input parameters may include, butare not limited to, patient age, height, weight, race, number ofpregnancies, number of live births, number of abortions, history ofrenal disease, active liver disease, history of hysterectomy, history ofcervical cancer, history of ovarian cancer, history of fibrocysticbreast disease, history of breast cancer, current follicle stimulatinghormone (FSH) level, current testosterone level, current estradiollevel, current non-pellet estradiol dose, history of acne or facialhair, history of hair loss, history of polycystic ovary syndrome (PCOS),history of heavy menses/fibroids, and history of metabolic syndrome.

If the patient type is a Female New Patient at block 403, once the inputparameters are input at process block 406, various lookup tables may beconsulted by the electronic circuit to determine various factors forestradiol and testosterone dosage calculation as well as dosageadjustment factors for various conditions and problems at process block408. Exemplary lookup tables used in an embodiment of the disclosure forfemale patients are shown below and may include Female EstradiolWeight/Age (Table 1), Female Estradiol Age (Table 2), Female EstradiolFSH (Table 3), Female Testosterone Weight (Table 4), Female TestosteroneAge (Table 5), Female Testosterone (Table 6), Conjugated Estrogen,Estradiols Pills, Estradiol Patch, Biestradiol Cream or Tabs, andProblem Factor. Exemplary tables used for HRT follow:

$

$

TABLE 1 Female Estradiol Weight/Age Weight/Age Ratio (lbs/Years) LookupValue (mg)   0-1.5 1 1.6-2.5 2 2.6-1.9 3 >4 2

TABLE 2 Female Estradiol Age Age (Years) Lookup Value <40 3 40-50 4551-60 15 61-68 12.5 >68

 4

TABLE 3 Female Estradiol FSH FSH Lookup Value  <31 0 31-50  1 51-1002 >100 3

TABLE 4 Female Testosterone Weight Weight (lbs.) Lookup Value (mg) 75-150 75 151-200 87.5 >200 100

TABLE 5 Female Testosterone Age Age (Years) Lookup Value 0-67 1 >67 0.63

TABLE 6 Female testosterone Testosterone Testosterone Lookup Value (mg)0-20 37.5 21-100 25 >100 0

After obtaining the lookup values from the various tables at processblock 408, additional problem adjustment factors may be determined atprocess block 410, disease history may be factored in at process block412, and other adjustments may be determined at process block 414. In anembodiment of the disclosure, these various considerations may include,but are not limited to: Female Estradiol Problem Factor, ConjugatedEstrogen, Estradiols Pills, Estradiol Patch, Biestradiol Cream or Tabs,and Problem Factor. Exemplary adjustment factors applied to the dosagedetermined after application of the lookup values to the base dosage,i.e., “test dosage” may include, but are not limited to: for history ofacne or facial hair, dosage=test dosage×0.90; history of hair loss,dosage=test dosage×0.88; hysterectomy, if YES, dosage=test dosage×0.88;history of PCOS, dosage=test dosage×0.75; history of heavy menses, ifYES, dosage=test dosage×0.88; history of metabolic syndrome, if YES, DONOTHING; persistent breast pain, if YES, dosage=test dosage×0.80;mid-cycle bleeding, if YES, dosage=test dosage×0.80; headache, if YES,dosage=test dosage×0.75; fluid retention, if YES, dosage=testdosage×0.75; and, fibrocystic breast disease, if YES, dosage=testdosage×0.70. Also, if the FSH is >=30 and age is between 20 and 50years, then the FSH adjustment lookup value is set to 12.5. In anothernon-limiting example, the FSH adjustment lookup is set to a value ≥10and ≤35 is the age is greater that or equal to 30.

Next, at process block 416, formula may be applied to determine femaledosage for estradiol and testosterone. Female dosage calculationsinvolve two calculations, one for estradiol and the other fortestosterone. The estradiol calculation involves calculating theweight/age ratio, age, current FSH levels, a problem factor multiplierand an FSH adjustment factor. The weight/age ratio is calculated bydividing the weight in pounds by the age in years. As indicated above,the weight/age ratio is then used to lookup the weight/age ratio lookupvalue from Table 1. The age is then used to lookup the lookup value inthe Female Estradiol Age lookup table (Table 2). The value of thecurrent FSH level is then used to find the corresponding lookup value inthe Female Estradiol FSH lookup table (Table 3). These values are thensummed into a single value and then multiplied by any problem factoradjustment values from process block 410, and added to the calculation.The estradiol dosage is thus calculated in Equation (1) as:

Estradiol dosage=((Weight Age Ratio Lookup+Age Lookup+FSHLookup)×Problem Factor)+FSH Adjustment

In one non-limiting example, the FSH lookup and the FSH adjustment forcalculating the estradiol dosage for female new or female returnpatients accounts for more that 50% of the estradiol dosage.

Similarly, the testosterone calculation involves calculating the weightlookup value, current testosterone level lookup value and testosteroneage lookup value. The weight is used to obtain a value from the FemaleTestosterone Weight lookup table (Table 4). The current testosteronelevel is used to obtain a value in the Female Testosterone lookup table(Table 5). These two values are then summed. The age is used to obtain avalue in the Female Testosterone Age lookup table (Table 6). Theobtained testosterone age lookup value is then multiplied by the sum ofthe testosterone weight and testosterone lookup values. The testosteronedosage is thus calculated in Equation (2) as:

Testosterone dosage=(Weight Testosterone Lookup+Testosterone LevelLookup)×Testosterone Age Lookup

Once the dosage is calculated at process block 418, exception logic maybe applied at process block 420 at the physician's discretion, forexample, for pre-menopausal women. For example, pre-menopausal femalesdo not receive estradiol except in the case where current estradiollevel is <10 or if the pre-menopausal female patient exhibits symptomsof migraines. For pre-menopausal women without estradiol level <10 ormigraines, estradiol calculated dose becomes 0.00. At process block 422,a final dosage for the new female patient is determination.

Like the dosage calculations for female new patients, female returndosage calculations, as indicated at process block 404, also involve twocomponents: one for estradiol and the other for testosterone. The methodincludes all the steps included for a new patient, and also determiningthe patient's previous dosage at process block 407 after receiving theinput parameters at process block 406. The previous dosage obtained atprocess block 407 may be directly input or may be saved in the database114 of FIG. 1. The female return patient estradiol dosage is thencalculated at process block 416 using the following Equation (3):

Estradiol dosage=((Weight Age Lookup+Age Lookup+FSH Lookup+Current DoseLookup)×Problem Factor)

Female Return Testosterone dosage is calculated using the followingEquation (4):

Testosterone dosage=(Weight Testosterone Lookup+Testosterone LevelLookup)×Testosterone Age Lookup

Calculation of female booster dosages, as shown at process block 405,for estradiol and testosterone is determined at process block 416,respectively, by taking the previous estradiol dosage and dividing by2.00, and taking the previous testosterone dosage and dividing by 3.00.In another non-limiting example, the estradiol and testosterone isdetermined at process block 416, respectively, by taking the previousestradiol dosage and dividing by a value that is greater than or equalto 1.5 and less than or equal to 3.0, and taking the previoustestosterone dosage and dividing by a value that is greater than orequal to 1.5 and less than or equal to 5.0.

Referring now to FIG. 5, the exemplary steps 500 for determining thedosage for a male patient are provided. To start the process fordetermining the dosage for the male patient, a patient type isidentified at decision block 502. The patient type may be determined bythe electronic circuit, as previously described with respect to FIG. 3.Additionally, or alternatively, the physician 110 of FIG. 1 may manuallyinput the patient type directly into the communication device 102 or,the patient type may be determined from the patient name and/or a uniqueidentification number combined with a lookup of patient informationstored in the database 114. The patient types identified at block 502may include: A Male New Patient, as shown at process block 503, whichmay be a male patient that has never been treated with HRT or someonewho has not received pellets for over ten months; A Male Return Patient,as shown at process block 504, which may be a male patient that has beentreated with HRT and is returning for ongoing treatment; Or a MaleBooster Patient, as shown at process block 505, which may be a malepatient that has been treated with HRT needing an additional dose priorto their next dose.

Once the patient type is identified, input parameters may be input intothe communication device, regardless of which patient type isidentified, at process block 506. The input parameters may include, butare not limited to, patient age, height, weight, race, history ofhypertension, history of diabetes, history of colon cancer, history oftesticular cancer, history of BPH, history of metabolic syndrome,physical activity level, history of prostate cancer, history of renaldisease, active liver disease and current testosterone level.

If the patient type is a Male New Patient at block 503, once the inputparameters are input at process block 506, various lookup tables may beconsulted by the electronic circuit to determine a base dosage fortestosterone and adjustment factors for various conditions and problems.Exemplary lookup tables used in an embodiment of the disclosure for malepatients include Male Age and Male Weight, Exemplary tables used for HRTfollow:

TABLE 7 Male Age Age (Years) Lookup Value <69 1 >68 0.8

TABLE 8 Male Weight Weight (lbs.) Lookup Value (mg) <151 1200 151-1751400 176-200 1600 201-225 1800 226-250 2000 251-275 2200 276-300 2400301-350 2600 351-400 2800 >400 3000

After obtaining the lookup values from the various tables at processblock 508, additional problem adjustment factors are determined atprocess block 510, disease history is factored in at process block 512,and other adjustments are determined at process block 514. In anembodiment of the disclosure, these various considerations may include,but are not limited to: Diabetes and Metabolic Syndrome. In the case ofDiabetes or Metabolic Syndrome, the testosterone dosage is increased by100 milligrams (mg), for example. Exemplary adjustment factors appliedto the dosage determined after application of the lookup values to thebase dosage, i.e., “test dosage” may include, but are not limited to:for history of BPH, dosage=test dosage×0.95; history of prostate cancer,dosage=test dosage×0.90; history of both prostate cancer and BPH,dosage=test dosage×0.90; physical activity level: sedentary/work only,decrease dosage by 100 mg, work+exercise 5 times/week, increase dosageby 100 mg; testosterone level >=700, no treatment; monthly testosteroneinjection (100-200 mg), no change in dosage; weekly testosteroneinjection (100-200 mg), increase dosage by 100 mg; testosterone gel(1.62%) used, increase dosage by 100 mg.

Next, at process block 516, formula may be applied to determine maledosage for testosterone HRT. Male dosage calculations involve a singlecalculation for testosterone. The testosterone calculation involvescalculating the weight lookup value, age lookup value, obtaining thecurrent testosterone dose value, if any, and applying any additionaladjustments (from above). As indicated above, the age is used to lookupthe age lookup value from Table 7. In one example, if the age lookupvalue is greater than or equal to 65, the testosterone dosage for a malenew, return or booster patient is between 10% and 50% less. The weightis then used to lookup the lookup value in the Male Weight lookup table(Table 8). These values are then multiplied together with the applicableadjustment factor to determine the testosterone dosage. The testosteronedosage is thus calculated in Equation (5) as:

Testosterone dosage=Age Testosterone Lookup×Weight TestosteroneLookup×other Adjustment Multiplication Factor

Dosage calculations for male return patients, as shown at process block504, are provided at process block 507 by application of the followingEquation (6):

If Current Testosterone Dosage<400.00 mg, then

Return Testosterone dosage=previous Testosterone Dosage+a value ≥200 and≤1000 mg;

Else

Return Testosterone dosage=previous Testosterone Dosage

Male booster testosterone dosage, as shown at process block 505, isdependent on existing or previous historical conditions such as BPH,cancer or combinations thereof, as included in the adjustment factorcalculated for male new patients, above. The booster testosterone dosageis then determined in Equation (7) as:

Booster testosterone dosage=previous testosteronedosage×(0.20×adjustment Multiplication Factor)

In other embodiments, the male booster testosterone dosage may bedetermined in Equation (8) as:

Booster testosterone dosage=previous testosterone dosage×(a value ≥0.20and ≤90 mg)×(adjustment Multiplication Factor)

Turning now to FIG. 6, a flow chart setting forth exemplary steps 600for automatically calculating an accurate recommended dosage for HRT andautomating a life cycle of a patient's treatment over time is provided.To start the process, a patient type is obtained at decision block 602.The patient type may be determined by the user, such as the physician110 of FIG. 1, for example, who may be prompted by the system to inputthe patient type directly into the user interface of the communicationdevice 102 of FIG. 1, for example. As shown in FIG. 7, an exemplary userinterface 230 of the communication device 102 is provided that promptsthe user to select one of the patient types 702. The patient types 702may include a Female New Patient, a Female Existing/Return Patient, aFemale Booster Patient, a Male New Patient, a Male Existing/ReturnPatient, and a Male Booster Patient.

Returning to FIG. 6, once the patient type is selected by the user, thesystem controller 210 may access the set of instructions 250, as shownin FIG. 2, to automatically determine whether the patient is a new orexisting patient at decision block 602. If the patient is a new patientat decision block 602, the system may prompt the user to add the newpatient's information at process block 604. In one embodiment, the usermay enter the new patient information prior to the patient's appointmentso that the user may select the newly entered patient to calculatedosing, as shown at process block 606, ahead of time. When the userselects a new patient on the user interface 230 shown in FIG. 7, a newpatient dialog screen 802 may be activated on the user interface 230, asshown in FIG. 8. Several fields 804 may be provided on the new patientdialog screen 802 for the user to fill in. The fields 804 may include,but at not limited to first name, last name, last four digits of thepatient's social security number, date of birth, height, and race of thepatient. Once the user enters the patient's date of birth and heightinto the corresponding fields 804, the age in years and the height ininches, for example, may be automatically calculated by the set ofinstructions stored in the system. Once the necessary new patientinformation is obtained, the user may click a save button 806 that willsave the patient information in the database 114, of FIG. 1, and open anew patient dosage calculation page, as will described in further detailbelow.

When the new patient's information is entered into the system by theuser ahead of time (i.e., prior to the patient's appointment), the usermay be provided with an exemplary patient list 902 displayed on the userinterface 230, as shown in FIG. 9. The patient list 902 may be presentedto the user after selecting a list patients button 904, which generatesa list of patients stored in the system database. The user may thenchoose the previously entered patient by using a search input field 906and clicking a search button 908 to find the newly entered patient. Thenew patient may be selected, for example, by clicking on the patientname displayed in the patient list 902, and the new patient dosagecalculation may be initiated at process block 606, as will be describedin further detail below. In addition, an add new patient button 910 maybe provided on the user interface 230 of FIG. 9 to allow the user tocreate a new patient record. This may be the case, for example, if theuser thought he/she entered the new patient's information prior to thepatient's appointment, but in reality did not. Clicking the add newpatient button 910 will direct the user back to the new patient dialogscreen 802 shown in FIG. 8.

Returning to FIG. 6, if the patient is an existing patient at block 602,the system may prompt the user to select the existing patient from apatient list, for example, at process block 608. FIG. 10 shows anexemplary patient list 1002 displayed on the user interface 230 that maybe presented to the user after searching for an existing patient using asearch input field 1004 and clicking a search button 1006. The user maythen choose an existing patient from the patient list 1002 at processblock 608. Additionally, the set of instructions stored on the systemcontroller can determine, based on dosing history and demographics, forexample, if the calculation is a Female New Patient, a FemaleExisting/Return Patient, a Female Booster Patient, a Male New Patient, aMale Existing/Return Patient, and a Male Booster Patient.

In the case where a returning patient has not previously been enteredinto the system, the user may select an add existing patient button 1008on the bottom to activate an existing patient dialog screen 1102 on theuser interface 230, as shown in FIG. 11. Several fields 1104 may beprovided on the existing patient dialog screen 1102 for the user to fillin. The fields 1104 may include, but at not limited to first name, lastname, last four digits of the patient's social security number, date ofbirth, height, and race of the patient. Once the user enters thepatient's date of birth and height into the corresponding fields 1104,the age in years and the height in inches, for example, may beautomatically calculated by the set of instructions stored in thesystem. Once the necessary patient information is obtained, the user mayclick a save button 1106 that will save the patient information in thedatabase 114, of FIG. 1, and open a patient dosage calculation page, aswill described in further detail below. If, however, the user decides toselect an existing patient from the list, a list patients button 1108may be provided on the existing patient dialog screen 1102 to return tothe patient list 1002 shown in FIG. 10.

Returning to FIG. 6, once the existing patient is chosen at processblock 608, the set of instructions 250, as shown in FIG. 2, areconfigured to automatically fill in patient information at process block609 based on patient records, patient medical history, previous dosingcalculations, and historical hormone insertions, for example. Thus,dosage accuracy may be increased by minimizing errors on the dosinginput screen and the amount of effort required to calculate a dose maybe decreased. Patient information obtained from the patient's recordsthat may automatically filled in at process block 609 may include, butis not limited to, patient age, weight, height, and race. Patientinformation obtained from the patient's medical history or the patient'sprevious dosing calculations that may be automatically filled in atprocess block 609 may include, but is not limited to, number ofpregnancies, number of live births, number of abortions/miscarriages,history of renal disease, active liver disease, hysterectomy, history ofcervical cancer, history of ovarian cancer, fibrocystic breast disease,history of breast cancer, can, facial hair, hair loss, history of PCOS,history of heavy menses/fibroids, history of metabolic syndrome,premenopausal, and menstrual migraines.

Thus, in one non-limiting example, if the patient has a history of renaldisease, the electronic circuit may be configured to store this medicalhistory corresponding to the patient. The electronic circuit may furtherbe configured to automatically display this relevant medical historycorresponding to the patient on the user interface for subsequent dosingsince, once identified, the patient will always have a history of renaldisease.

FIG. 12 shows an exemplary dosing calculation page 1202 that may bedisplayed to the user on the user interface 230 once the patientinformation has been entered or selected. In addition, many of thevalues on the dosing calculation page 1202 may automatically be filledin. For example, age 1204 may automatically be calculated from the dateof birth previously acquired, and race 1206, height 1208, and weight1210 may automatically be filled in per the patient's stored profile. Inone embodiment, weight 1210 may be changed directly on the dosingcalculation page 1202, as weight may fluctuate with each visit. Symptoms1212 may also automatically be filled in per the latest dosagecalculation on record. Previous Estradiol dose 1214 may automatically befilled in based on the last full dosage on file for the return orbooster patient. The system uses the actual historical inserted dosebased on the pellets inserted to calculate the previous estradiol dose1214. The previous estradiol dose 1214 is different from the calculatedestradiol dose 1218 since it is often not possible to obtain the exactcalculated dose as the pellets are in discrete amounts, as will bediscussed in further detail below. Thus, the last full-dose (i.e., thenon-booster dose) is used to calculate the previous estradiol dose 1214.Alternatively, the previous estradiol dose 1214 can be manually changedfor the purposes of the dose calculation. Previous Testosterone dose1216 may also automatically be filled in based on the last full dosageon file for the return or booster patient. The system uses the actualhistorical inserted dose based on the pellets inserted to calculate theprevious testosterone dose 1216. The previous testosterone dose 1216 isdifferent from the calculated testosterone dose 1220 since it is oftennot possible to obtain the exact calculated dose as the pellets are indiscrete amounts. Thus, the last full-dose (i.e., the non-booster does)is used to calculate the previous testosterone dose 1216. Alternatively,the previous testosterone dose 1216 can be manually changed for thepurposes of the dose calculation.

Returning again to FIG. 6, once the patient information is added atprocess block 604 for a new patient, or automatically filled in atprocess block 609 for an existing patient, the dosage may be calculatedat process block 606. The dosage calculation may be computed for bothnew and existing patients at process block 606, and thus, the samereference numerals will be used to describe the remaining steps 600 ofthe process. In one embodiment, the dosage may be calculated aspreviously described with respect to the estradiol dosage andtestosterone dosage calculations in equations 1 through 8 and thecorresponding look up tables 1 through 8.

Once the dosage is calculated at process block 606, the system allowsthe user to decide whether the calculation type (e.g., New ReturnBooster), is appropriate at decision block 608. If the user deems thecalculation type inappropriate at process block 608, the dosage may berecalculated at process block 606. However, if the user deems thecalculation type appropriate at process block 608, the user is providedan option to manually adjust the calculation at decision block 610. Ifthe system recognizes that the user does not manually adjust thecalculation at decision block 610, the system will prompt the user toprescribe the calculated dosage at process block 612. However, if thesystem recognizes that the user manually adjusts the calculation atprocess block 610, the system may record a manually adjusted dosage atprocess block 614. The system will then prompt the user to prescribe thecalculated dosage at process block 612.

Referring again to FIG. 12, the system may prompt the user to prescribethe calculated dosage by proving a prescribe button 1222. Clicking theprescribe button 1222 may activate the set of instructions stored on thesystem controller to display a prescribe patient dialog screen 1302 onthe user interface 230, as shown in FIG. 13. The prescribe patientdialog screen 1302 may include calculated dosages 1303, the patient'sname, gender and age, and a past insertion history 1306. The patient'spast insertion history 1306 may include, for example, the patient's lastfour insertions, the date of insertion, the estradiol insertion amountin mg, the testosterone insertion amount in mg, the insertion side andthe calculation type. As such, the patient's past insertion history 1306may help support the user's decision making related to a patient'sdosages, for example. In one non-limiting example, the patient's pastinsertion history 1306 may be used to identify an insertion time framefor return dosing for a return or booster patient.

Upon creating the prescription, the system may provide the user withfields on the prescribe patient dialog screen 1302 to enter prescriptioninformation. As shown at process block 616 of FIG. 6, the prescriptioninformation to be provided may include, but is not limited to, insertionlocation of the pellet, insertion side, pellet dose, lot numbers andinsertion notes about the insertion, all of which may be saved in thepatient historical profile.

Insertion location of the pellet may be in the patient's hip or abdomen,for example. Based on the historical insertion information for thepatient, the system may default the insertion location value based onthe previous insertion, as shown on the prescribe patient dialog screen1302 in FIG. 13. If the previous insertion location is in the abdomen,for example, the abdomen will be automatically selected. Alternatively,the user may choose to manually change this value. The insertion side1304 (i.e., left or right) of the pellet may be based on historicalinsertion information 1306 for the patient. Similar to the insertionlocation, the system may default the insertion side value based on theprevious insertion. For example, if the previous insertion side is onthe left, the system will automatically select the opposite side (i.e.,the right), as shown in FIG. 13. Alternatively, the user may choose tomanually change this value. As such, the system may take the manuallyentered values corresponding the insertion side and/or location andstore them for future dose calculations for the particular patient.

The pellet dose 1308 may be based on the calculated dose, and the systemmay automatically suggest the combination of pellets that most closelymatches the calculated dosage and that yield the least number ofpellets, as shown at process block 618 in FIG. 6. As shown in FIG. 13,this is performed for both estradiol and testosterone. The user maymanually modify the pellets suggested by the system by clicking on afirst icon 1310, such as a plus sign icon, and a second icon 1312, suchas a minus sign icon, to increase or decreases the number of pellets,respectively. The system may automatically calculate the pellet dose1308 based on the pellet sizes chosen and automatically update thepellet dose 1308 totals as the user adds or subtracts pellets. As anon-limiting example, the case where the calculated estradiol dose is 25mg, the system may suggest two pellets, namely one 15 mg pellet and one10 mg pellet. However, the user may choose to use two 12.5 mg pellets.Or the user may use his or her discretion to dose a 12.5 mg pellet and a10 mg pellet using a total of 22.5 mg which is less than the calculateddosage. Whatever the final dosage is selected, the system tracks theactual historical insertion amount.

In another embodiment, the pellet dose 1308 may be automaticallycalculated at process block 618 in FIG. 6 using a pellet allocationalgorithm, for example. The pellet allocation algorithm, as shown inAppendix A, may be accessed by the set of instructions stored on thesystem controller to accurately determine optimal pellet insertion givena calculated dosage. Because pellets are in discreet amounts, it isoften not possible to insert the exact calculated amount. For example,conventional testosterone pellets are typically available is thefollowing dosages: 25 mg, 37.5 mg, 50 mg, 87.5 mg, 100 mg, and 200 mg.Similarly, conventional estradiol pellets are typically available in thefollowing dosages: 6 mg, 10 mg, 12.5 mg, 15 mg, 18 mg, 20 mg, 22 mg, and25 mg. In order to calculate the optimal pellet insertion dosage, thepellet allocation algorithm uses the best available approximation, suchthat the system should produce a final dosage as close to the calculateddosage amount as possible. For instance, if the calculated dosage is36.75 mg in estradiol, the system may choose a 20 mg+18 mg=38 mg over asub-optimal allocation of 20 mg+15 mg. There is no bias to the finaldosage being greater or less except in the case of the bias being equal,then the system chooses less. The pellet allocation algorithm also usesthe least number of pellets to determine the optimal pellet insertion.Since each pellet is an extra subcutaneous insertion, the system targetsa pellet combination that minimizes the number of pellets. For example,given a calculated dose of 25 mg estradiol, the system may choose one 25mg estradiol instead of two 12.5 mg estradiol or one 10 mg and one 15 mgestradiol to achieve the same result. In addition, the pellet allocationalgorithm may incorporate some specific biases based on real worldexperience. For large testosterone doses, a normally suggested single200 mg is broken into two 100 mg to speed up initial hormone absorptionby the body, for example.

The base pellet allocation algorithm, shown in Appendix A, uses a nestedloop strategy, such that, for each pellet size starting from the largestto smallest, the pellet size is subtracted from the calculated dose andthe result is evaluated. If the result of the subtraction is less thanzero then the next smallest pellet size is subtracted from thecalculated does and the result is evaluated. If the result of thesubtraction is less than zero, then the next (smaller) pellet size issubtracted from the calculated dose. This process is repeated until theresult of the subtraction is greater than zero—once greater than zero.If the result of the subtraction is greater than zero, the previouspellet amount result (negative) and the current pellet amount (positive)are compared, and the lesser of the absolute value of the previouspellet amount and the current pellet amount is taken to obtain theclosest approximation.

Thus, the pellet allocation algorithm yields a suboptimal approximationin cases where a combination of lesser pellet sizes yields a betterapproximation when the calculated dose allows for a larger pellet sizeto be used. For example, if the calculated testosterone is 112.5 mg,based on the base allocation algorithm above, the algorithm would yieldone 100 mg testosterone pellet. However, a combination of 87.5 mg+25 mgyields an exact amount. This problem may solved by iterating the basealgorithm (above) with the largest pellet being a smaller size with eachsuccessive iteration. For instance, the base algorithm would be re-runwith the largest testosterone pellet size of 100 mg (sans the 200 mgpellet). If a closer approximation results, then that is taken. If not,the base algorithm is run again with the largest pellet size being thenext smallest down. In this instance, the base algorithm is re-run with87.5 mg being the largest pellet size (sans the 100 mg pellet). On thisiteration, the system would arrive at a better approximation than theoriginal run. The iterations would only go on until an exact match isfound (in which case there is no longer a need to search for a betterapproximation) or until the maximum pellet is also the smallest pellet.If a particular iteration yields a solution that is not better than theprevious (defined by a smaller absolute value of the difference from thecalculated value), then the previous solution is used because itguarantees a lesser number of pellets.

Once the pellet dose is automatically calculated at process block 618,the user may be provided an option to manually enter the estradiolpellet size insertion and the testosterone pellet size insertion, ratherthan using the estradiol pellet size insertion and the testosteronepellet size insertion determined by the pellet insertion algorithm.Next, the user may enter the lot numbers corresponding to the pellets tobe inserted into the patient at process block 616. Lot number fields1314, as shown in FIG. 13, may be provided on the prescribe patientdialog screen 1302 for the user to enter the corresponding lot numbers1501, as shown in FIG. 15. For compliance to health safety rules, allpellets inserted into patients must have the pellet's lot numberrecorded. Thus, the system creates lot number fields 1314 for eachpellet chosen. In the case above, the system would create two lot numberfields 1314 to enter the 12.5 mg pellet and the 10 mg pellet. In thecase where multiple pellets of the same size are inserted, the systemwill create lot number fields 1314 for each pellet. For example, if two12.5 mg pellets are chosen, the system will create two lot numberfields. If there are multiple lot number fields of the same pellet typeand size, a copy icon 1502, as shown in FIG. 15, can copy the lot numberof the pellet above. It is often the case that the similar type and sizepellets carry the same lot number. In addition, once lot numbers areentered into the system, the user may use a search lot numbers function1602, as shown in FIG. 16, to find lot numbers by patient name, lotnumber, and insertion date range, for example.

Once the insertion location of the pellet, insertion side, pellet dose,lot numbers and insertion notes about the insertion are obtained atprocess block 616 in FIG. 6, another user, for example a medicalassistant, may adjust the patient information and enter new patientinformation, such at a blood work number, at process block 620. Eachtime a patient returns for additional dosages, the steps 600 arerepeated for the existing patient and saved in the patient's profile forfuture dosage calculations.

In yet another embodiment, the dosage system may consider the number ofreturn visits when factoring the calculated dosing value. For example,upon the first return of a female dosing patient, the testosteronedosage amount may be reduced by 12.5 mg prior to taking into accounthistorical factors. Previously, the return calculation for females wasdriven by the previous testosterone dose multiplied by historicalfactors. The historical factors being, but not limited to, acne, facialHair, and history of PCOS. The new calculation is as follows in Equation(9):

Testosterone dosage=(previous testosterone dose−12.5)*historical factors

As shown in FIG. 14, a patient information dialog screen 1402 is shownon the user interface 230 of the communication device. The patientinformation dialog screen 1402 may display the patient's insertionhistory 1404. In the embodiment shown in FIG. 14, when the user clickson the new patient button 910 of FIG. 9, the patient information dialogscreen 1402 is displayed on the user interface 230. The patientinformation can be modified by the user prior to clicking the savebutton 1406.

In addition to the factors used to calculate the dosage in equation (9)above, non-pellet testosterone usage may be incorporated. For example,if non-pellet testosterone is indicated in the calculation, thentestosterone calculation is set to 0.00. In addition, or alternatively,if a return patient is premenopausal and their current estradiol levelis greater than 10 mg, for example, and the patient does not showsymptoms of menstrual migraines, then the estradiol return and boostercalculation is set to 0.00. Physical activity level may also beincorporated into the dosage calculation. The physical activity level ofthe patient may include, but is not limited to, sedentary/work only,work plus exercise three times per week, and work plus exercise fivetime per week. If the activity level of the patient is indicated assedentary/work only, the dosage calculation may be configured todecrease the testosterone dose by 100.00 mg, for example. If theactivity level of the patient is indicated as work plus exercise threetimes per week or work plus exercise five time per week, the dosagecalculation may be configured to increase the testosterone dose by anappropriate mg and 100.00 mg, respectively. In addition, if the patienthas a history of BPH, the dosage calculation may be configured todecrease the testosterone calculation by 5%, for example. Alternatively,if the patient has a history of prostate cancer, the dosage calculationmay be configured to decrease the testosterone calculation by 5%. Or ifthe patient has a history of both BPH and prostate cancer, the dosagecalculation may be configured to decrease the testosterone calculationby 10%, for example.

In one exemplary embodiment, the above-described dosing system mayinclude a comprehensive toolkit for providing hormone replacementtherapy. The comprehensive toolkit may provide ancillary supportfunctions, including, but not limited to, patient consult requests andresponse, articles, videos, forms, news and updates, productspurchasing, financial reports, and assistant assignments.

The patient consult function may allow users to submit a question for aparticular patient, for example. To begin a patient consult, the systemmay securely route the consult request electronically to SottopelleTherapy headquarters, for example. A notification email may then be sentalerting staff of the HRT provider and the consult request can be pulledfrom a database application. A response can be written into the consultrequest record, and a notification email may be sent to the providerrequesting the consult that their consult request has been responded to.The user can go to a patient consults area where they can securely viewpast and present patient consults.

Users can initiate a patient consult request by filling out informationabout the patient using a form 1700, as shown in FIG. 17. The systemwill automatically fill in patient information based on the patientselected. The following fields are available to describe the patient'ssituation: patient last name, age, weight, gender, relevant medicationand supplements, relevant patient history, patient symptoms,hysterectomy, both ovaries removed, lab results label, E2, T-total, PSA,T-free, total T3, free T4, FSH, TSH, previous labs and dosages, date,previous labs: E2, previous dosage: E2, previous labs: test, previousdosage: test, previous labs: FSH, date, previous labs: E2, previouslabs: test, previous dosage: E2, previous dosage: test, previous labs:FSH, your choice, your choice: E2, your choice: test. Once the form 1700is submitted, the provider is notified via email and the patient consultrequest record becomes visible in the patient consult responseapplication.

The system may display consult requests 1800 awaiting response, as shownin FIG. 18, as well as a tab 1802 for past patient consults, to allowusers to edit the patient consult records and submit a response. Usersmay respond to a patient consult with some or all patient consultinformation conveniently visible, as shown in FIG. 19. Once a responseis submitted, the provider is notified via email and the patient consultresponse record becomes visible in the patient consult responseapplication. Users may also be provided with the status of the patientconsult requests 1800, as shown in FIG. 20, indicating if the responseis available or unavailable, for example. The patient consult concludeswith a printable page of all relevant parameters along with a responseto the particular patient's condition and recommended course of action,as shown in FIG. 21.

In one embodiment, the system offers informational resources pertainingto hormone replacement therapy articles, videos, forms, news andupdates, as shown in FIG. 22. News videos and updates may include, butare not limited to Instagram videos, Twitter texts, Facebook posts,Pinterest photos, Sottopelle and Hormone Replacement Therapy News,marketing brochures, office forms, important articles, and instructionalvideos. As shown in FIG. 23, users may also search through relevantarticles on hormone replacement therapy by entering a search term. Thesystem can then access the web-based library to obtain the latestresearch, resources and information on HRT and pellets. Further, asshown in FIG. 24, the system allows for the following products to bepurchased including, but not limited to, hair repair, DIM, health andwellness, oil of evening primrose, calcium pyruvate, liquid vitamin D3,traumeel tablets, sleep wellness, slow flow, TrocarPak female, TrocarPakmale, male trochar kit, and female trochar kit.

The dosing system may also provide tools for tracking revenues perpatient visit. By doing so, the system can generate end-of-day top linereports on a per office level to providers needing to get a clearerfinancial picture of their practice. The system can automaticallypopulate a pellet calendar 2500, shown in FIG. 25, with patientprescriptions as described previously. Medical assistants, for example,as well as providers can view the pellet calendar 2500 which allows forfinancial numbers to be assigned to each prescription. Users can do thisby clicking on a day 2502. The system automatically populates a dailypellet list 2600, as shown in FIG. 26, allowing users to enter financialinformation attached to each visit. The daily pellet list 2600 may show,but is not limited to, the following values: patient name, age, visittype (new/return/booster), gender (male/female), estradiol pelletsinserted during the visit, and testosterone pellets inserted during thevisit

In another embodiment, the system provides a patient insertion superbillmodal window 2700, shown in FIG. 27, that allows for patient checkoutamounts to be attached to each patient visit. The patient informationand pellet insertion amounts may all automatically be pre-filled andinclude: patient name, age, visit type (new/return/booster), gender(male/female), estradiol pellets inserted during the visit, andtestosterone pellets inserted during the visit. Thus, the users canenter financial information (e.g., cash, credit, debit, check) into thesuperbill modal window 2700 and totals 2702 can be automaticallycalculated.

The financial information and patient visits can be summarized toprovide a full financial view of the practice in the form of an end ofday (EOM report 2800, as shown in FIG. 28. The following metrics mayautomatically be calculated and displayed in a format that can beprinted and emailed: (1) Daily totals: cash, credit, debit, check andgrand total; (2) Month To Day Totals: cash, credit, debit, check andgrand total—includes a date range search; (3) Daily Total Patient: countpatients for the day for each gender; and (4) Month to Day TotalPatients: count patients for the day for each gender and may includes adate range search.

The financial numbers may be aggregated for the provider to track thenumber of patients, prescription and pellets to manage day-to-dayoperations including patient and gender count per provider for a givendate range, revenues per provider for a given date range, and dosing feeper provider for a given date range. The financial numbers may bedisplayed in the form of a prescription summary report 2900, forexample, as shown in FIG. 29.

The system may be a full multi-user system allowing providers to createsecure login for assistants, for example, to interact with patients,pellet insertions, and other patient visit information. The systemautomatically keeps track of which login belongs to which provider sowhen the assistant logs in, only patients related to the correspondingoffice are shown. Multiple providers 3000 can be linked to the sameoffice 3002, as shown in FIG. 30, allowing multiple providers in thesame office to share patient information, and allowing a provider record3100 to specify an office, as shown in FIG. 31. Likewise, a medicalassistant login 3200 may be linked to a provider, as shown in FIG. 32.

In many embodiments the method for calculating dosages for hormonereplacement therapy may be modified to accommodate hormone therapy for aFemale-to-Male (FTM) or Male-to-Female (MTF) transgender patient. Aswith Female and Male patients, the system may automatically detect apatient status for FTM and MTF patients such as a new patient, returningpatient, or booster patient.

Referring now to FIG. 33, a flowchart showing an exemplary embodiment ofthe method 3300 for calculating effective dosages for a FTM patient. Thepatient type may be determined as previously described with respect toFIG. 3. Additionally, the user may manually enter the patient type viathe input device as FTM New 3303, FTM Return 3304, or FTM Booster 3305.When calculating the dose for a FTM New 3303 patient undergoingmasculinizing hormone therapy, the FTM testosterone dosage calculator inmany embodiments uses the male gender option in the lookup tables 3308and formula 3316 and increases the dosage 3318 by approximately 400 mg.

As discussed with regard to FIG. 5 above, the effective testosteronedosage may be modified based on a plurality of factors. In addition tothose factors previously presented, a FTM patient's testosterone dosagemay be further adjusted based on other input parameters 3306 such asbone density, aggression, and the FTM patient's development of masculinecharacteristics. In many embodiments the dosage 3318 may be furthermodified by disease history 3312, other adjust 3314 factors, andphysician discretion 3320. If the FTM patient shows signs of increasedaggression, the system may suggest that the testosterone dosage bereduced by approximately 200-400 mg. An exemplary table of potentialphysical changes for the input parameters for the FTM patient ispresented below:

Table of effects and potential time course of masulinizing hormones**Potential Potential Expected Maximum Potential Effect Onset* Effect*Skin oiliness/acne 1-6 months 1-2 years Facial and body hair growth 3-6months 3-5 years Scalp hair loss >12 months*** Variable Increased musclemass/strength 6-12 months 2-5 years (significantly dependent on amountof exercize) Body fat redistribution 3-6 months 2-5 years Cessation ofmenses 2-6 months NA Clitoral enlargement 3-6 months 1-2 years Vaginalatrophy 3-6 months 1-2 years Deepened voice 3-12 months 1-2 years

In some embodiments the input parameters 3306 may also include absolutecontraindications for masculinizing hormone therapy such as pregnancy,unstable coronary artery disease, and untreated polycythemia with ahematocrit of 55% or higher. When these or other absolutecontraindications are present, the display may alert the user via apopup. In these and other embodiments the input parameters 3306 mayfurther include whether the FTM patient's reproductive organs are stillintact. If the FTM patient's reproductive organs are still intact thedisplay may alert the user via a popup that a mammogram and yearlypelvic exams are recommended for the patient.

In addition to the increased testosterone dosage, a user may alsoadminister to the FTM New 3303 patient approximately 2.5 mg of letrozoletwice a month. In some embodiments a dosage 3318 may also includesubject to physician discretion 3320 progestins, such asmedroxyprogesterone, or GnRH agonists. In these and other embodimentsthe physician may further modify the pellet to be aTestosterone+anastrozole pellet. After administering the initialeffective dosage, labs for the patient's E2, Total Estrogens, TotalTestosterone, and Free Testosterone should be drawn betweenapproximately 4 and 6 weeks from pellet insertion. If the lab value fortestosterone is between 600 and 800 ng/dl a booster dosage oftestosterone may be suggested by the system. In some embodiments a FTMBooster 3305 patient's dosage is further modified based on a previousdosage 3307. After this follow-up, the FTM Return 3304 patient requiresa reinsertion approximately every 5-8 months, with lab results prior toeach reinsertion being checked against an expected testosterone ofbetween approximately 600-800 ng/dl by the processor.

Referring now to FIG. 34 a flowchart showing an exemplary embodiment ofthe method 3400 for calculating effective dosages for a MTF patient. Thepatient type may be determined as previously described with respect toFIG. 3. Additionally, the user may manually enter the patient type viathe input device as MTF New 3403, MTF Return 3404, or MTF Booster 3405.When calculating the dose for a MTF New 3403 patient undergoingfeminizing hormone, the MTF estradiol and testosterone dosage calculatorin many embodiments uses the female gender option in the lookup tables3308 and formula 3316 and will generally receive between approximately100 to 125 mg of estradiol and no testosterone on the first visit.

As discussed with regard to FIG. 4 above, the effective estradiol andtestosterone dosages may be modified based on a plurality of factors. Inaddition to those factors previously presented, MTF patient's estradioland testosterone dosage may be further adjusted based on other inputparameters 3406 such as end-stage chronic liver disease, tobacco use,and development of feminine characteristics. In many embodiments thedosage 3418 may be further modified by disease history 3412 such ashistory of venous thrombotic events, history of estrogen-sensitiveneoplasm, unstable coronary artery disease, cardio or cerebrovasculardisease, or untreated polycythemia. In some embodiments the dosage 3418may also be modified by other adjust 3414 factors or physiciandiscretion 3420. An exemplary table of potential physical changes forthe input parameters for the MTF patient is presented below:

Table of effects and potential time course of femalizing hormones**Potential Potential Expected Maximum Potential Effect Onset* Effect*Body fat redistribution 3-6 months 2-5 years Decreased muscle 3-6 months1-2 years mass/strength (significantly dependent on amount of exercize)Softening of skin/ 3-6 months Unknown decreased oiliness Decreasedlibido 1-3 months 1-2 years Decreased spontaneous 1-3 months 3-6 monthserections Male sexual Variable Variable dysfunction Breast growth 3-6months 2-3 years Decreased testicular 3-6 months 2-3 years volumeDecreased sperm Variable Variable production Thinning and slowed 6-12months  >3 years growth of body and (complete removal of male facialhair facial hair and body hair requires electrolysis, laser hair removalor both) Male pattern baldness No regrowth, 1-2 years loss stops 1-3months

In some embodiments the input parameters 3406 may also include absolutecontraindications for feminizing agents such as estrogen. In these andother embodiments the absolute contraindications include venousthrombotic events related to underlying hypercoagulable condition,history of estrogen-sensitive neoplasm, and end-stage chronic liverdisease. When these or other absolute contraindications are present, thedisplay may alert the user via a popup. In these and other embodimentsthe input parameters 3406 may further include whether the MTF patient'sreproductive organs are still intact. If the MTF patient's reproductiveorgans are still intact the display may alert the user via a popup thata prostate exam is recommended for the patient.

In addition to estradiol, the user may also administer to the MTF New3403 patient between approximately 25-50 mg of spironolactone twicedaily as part of physician discretion 3420 in determining the finaldosage 3422. After administering the initial effective dosage, labs forthe patient's E2, Total Testosterone, Free Testosterone, and ProstateSpecific Antigen (PSA) should be drawn between approximately 4 and 6weeks from pellet insertion. If the lab value for estradiol is between200 and 400 pg/ml a booster dosage of estradiol may be suggested by thesystem. In some embodiments a MTF Booster 3405 patient's dosage isfurther modified based on a previous dosage 3407. After this follow-up,the MTF Return 3404 patient requires a reinsertion approximately every3-6 months, with lab results prior to each reinsertion being checkedagainst an expected estradiol of between approximately 200-400 pg/ml bythe processor.

The present invention has been described in terms of one or morepreferred embodiments, and it should be appreciated that manyequivalents, alternatives, variations, and modifications, aside fromthose expressly stated, are possible and within the scope of theinvention.

In places where the description above refers to particularimplementations of systems and methods for automated dosage calculationand patient treatment life cycle for a transgender patient, it should bereadily apparent that a number of modifications may be made withoutdeparting from the spirit thereof and that these implementations may beapplied to other to systems and methods for automated dosage calculationand patient treatment life cycle for a transgender patient.

I/We claim:
 1. A computer-implemented method of providing a dosage and atransgender patient treatment lifecycle comprising: receiving, by acomputerized device comprising a processor, an input device, and adisplay screen, an input signal of a user indicating an input directedto a patient sex and a patient status, wherein the patient status isautomatically determined by the processor and includes at least one of anew patient, a returning patient and a booster patient; determining bythe processor an effective estradiol dosage and an effectivetestosterone dosage using dosage calculation methods selected based onthe patient status, automated male-to-female input parameters, andmale-to-female tracking parameters in response to receiving an inputindicating that the patient sex is male-to-female; determining by theprocessor an effective testosterone dosage using dosage calculationmethods selected based on the patient status, automated female-to-maleinput parameters, and female-to-male tracking parameters in response toreceiving an input indicating that the patient sex is female-to-male;displaying on the display screen, the determined effective dosages; andadministering a pellet comprising at least one of the determinedeffective dosages to the patient.
 2. The method according to claim 1,wherein the automated male-to-female input parameters and the automatedfemale-to-male input parameters comprise at least one of a physicalactivity level, a quantity of patient visits, patient age, patientheight, weight, race, number of pregnancies, number of live births,number of abortions, history of renal disease, history of active liverdisease, hysterectomy, history of cervical cancer, history of ovariancancer, history of fibrocystic breast disease, history of breast cancer,current follicle stimulating hormone (FSH) level, current testosteronelevel, current estradiol level, history of acne, history of facial hair,history of hair loss, history of prostate cancer, history of polycysticovary syndrome (PCOS), history of hysterectomy, history of heavy menses,history of metabolic syndrome, history of venous thrombotic events,history of estrogen-sensitive neoplasm, end-stage chronic liver disease,tobacco use, unstable coronary artery disease, untreated polycythemia,hematocrit level, cardiovascular disease, cerebrovascular disease, bonedensity, aggression, development of feminine characteristics, anddevelopment of masculine characteristics.
 3. The method according toclaim 2, further comprising automatically calculating, by the processor,at least one of the patient age based on a date of birth entered intothe input device by the user and the patient height based on a heightparameter entered into the input device by the user.
 4. The methodaccording to claim 2, wherein the dosage method for a male-to-femalebooster and return patient further comprises: receiving, by theprocessor at least one of a level of estradiol, a level of totaltestosterone, a level of free testosterone, and a level ofprostate-specific antigen of the patient; determining, by the processor,an estradiol dosage in response to receiving an indication that thelevel of estradiol of the patient that is between approximately 200 and400 pg/ml; and determining, by the processor, an anti-androgen dosagebased on at least one of the level of total testosterone, the level offree testosterone, and the level of prostate-specific antigen.
 5. Themethod according to claim 2, wherein the dosage method for afemale-to-male booster and return patient further comprises: receivingby the processor at least one of a level of estradiol, a level of totalestrogens, a level of total testosterone, and a level of freetestosterone of the patient; determining, by the processor, atestosterone dosage in response to receiving an indication that thelevel of total testosterone is between approximately 600 and 800 ng/dl;and determining, by the processor, at least one of a letrozole dosageand an anastrozole dosage based on at least one of the level ofestradiol and the level of total estrogens.
 6. The method according toclaim 1, wherein determining the effective dosages is based on inputparameters comprising at least one of a physical activity level, aquantity of patient visits, patient age, patient height, weight, race,number of pregnancies, number of live births, number of abortions,history of renal disease, history of active liver disease, hysterectomy,history of cervical cancer, history of ovarian cancer, history offibrocystic breast disease, history of breast cancer, current folliclestimulating hormone (FSH) level, current testosterone level, currentestradiol level, history of acne, history of facial hair, history ofhair loss, history of prostate cancer, history of polycystic ovarysyndrome (PCOS), history of hysterectomy, history of heavy menses,history of metabolic syndrome, history of venous thrombotic events,history of estrogen-sensitive neoplasm, end-stage chronic liver disease,tobacco use, unstable coronary artery disease, untreated polycythemia,hematocrit level, cardiovascular disease, cerebrovascular disease, bonedensity, aggression, development of feminine characteristics, anddevelopment of masculine characteristics.
 7. The method according toclaim 1, further comprising displaying a past insertion history on thedisplay screen corresponding to the patient, wherein the past insertionhistory includes at least one of a previous insertion date, a previoustestosterone dose, a previous estradiol dose, a pellet insertionlocation, and a pellet insertion side.
 8. The method according to claim7, further comprising identifying, using the past insertion history, aninsertion time frame for return dosing for at least one of the returningpatient and the booster patient.
 9. The method according to claim 7,further comprising displaying the previous insertion date, the previoustestosterone dose, the previous estradiol dose, the pellet insertionlocation, and the pellet insertion side on the display screen for theuser at a time of insertion.
 10. The method according to claim 7,further comprising identifying, by the user, a new pellet insertionlocation based on at least one of the pellet insertion location, theprevious insertion date, the previous testosterone dose and the previousestradiol dose provided by the past insertion history on the displayscreen.
 11. The method according to claim 1, wherein using dosagecalculation methods selected based on the male-to-female trackingparameters and the female-to-male tracking parameters comprises trackingat least one of a pellet insertion location, a pellet insertion side, apellet dose, a pellet lot number, an insertion note, a previoustestosterone dose, and a previous estradiol dose.
 12. The methodaccording to claim 11, further comprising automatically displaying atleast one of the previous estradiol dose and the previous testosteronedose on the display screen of the input device, wherein the previousestradiol dose and the previous testosterone dose are based on a lastfull dosage, the last full dosage being different from at least oneprevious effective dosage.
 13. The method according to claim 11, whereintracking the pellet insertion location and the pellet insertion side isbased on historical insertion information including at least one of ahip location, an abdominal location, a left side, and a right side; andwherein, based on the historical insertion information, the pelletinsertion location and the pellet insertion side are automaticallysuggested by the processor.
 14. The method according to claim 13,further comprising providing an option to the user to manually input atleast one of the pellet insertion location and the pellet insertionside, the at least one of the pellet insertion location and the pelletinsertion side being different from the pellet insertion location andthe pellet insertion side automatically suggested by the processor. 15.The method according to claim 11, wherein tracking the pellet lot numbercomprises entering one or more corresponding lot numbers into at leastone lot number field provided on the display screen of the input device.16. The method according to claim 1, further comprising determining bythe processor an estradiol pellet size insertion corresponding to theeffective estradiol dosage and a testosterone pellet size insertioncorresponding to the effective testosterone dosage using a pelletallocation algorithm, wherein a quantity of the estradiol pellet sizeinsertion and the testosterone pellet size insertion are minimized. 17.The method according to claim 16, further comprising providing an optionto the user to manually input at least one of the estradiol pellet sizeinsertion and the testosterone pellet size insertion, the at least oneof the estradiol pellet size insertion and the testosterone pellet sizeinsertion being different from the estradiol pellet size insertion andthe testosterone pellet size insertion determined by the pelletallocation algorithm.
 18. The method according to claim 16, furthercomprising: ordering, by the processor, a plurality of pellet sizes fromlargest to smallest; subtracting, by the processor, a largest of theplurality of pellet sizes from the effective dosage; and if a result ofthe subtraction is greater than zero, assigning, by the processor, thelargest of the plurality of pellet sizes as the estradiol pellet sizeinsertion or the testosterone pellet size insertion; if a result of thesubtraction is less than zero, subtracting, by the processor, a nextsmallest one of the plurality of pellet sizes from the effective dosageuntil the result is greater than zero; calculating, by the processor, anabsolute value of the result of the subtraction that is less than zeroand an absolute value of the result of the subtraction that is greaterthan zero; and assigning, by the processor, one of the plurality ofpellet sizes as the estradiol pellet size insertion or the testosteronepellet size insertion corresponding to the result having a lesserabsolute value.
 19. The method according to claim 1, further comprising:displaying, by the display, an estradiol pellet size insertioncorresponding to the effective estradiol dosage and a testosteronepellet size insertion corresponding to the effective testosteronedosage; receiving, by the input device, another input signal of the userindicating at least one of an increase and a decrease in at least one ofthe estradiol pellet size insertion and the testosterone pellet sizeinsertion; and calculating, by the processor in real-time, an updatedeffective estradiol dosage and an updated effective testosterone dosagebased on the input signal of the user.
 20. The method according to claim1, wherein using the dosage calculation method comprises incorporating areturn visit associated with the patient to determine at least one ofthe effective estradiol dosage and the effective testosterone dosage.21. The method according to claim 1, further comprising providing acomprehensive toolkit on the input device, the comprehensive toolkit kitcomprising at least one of an ancillary support function, a patientconsult request a patient consult response, an article, a video, a form,news, an update, a product purchase order, a financial report, and anassistant assignment related to the dosage and patient treatmentlife-cycle.
 22. The method according to claim 1, further comprising:tracking, using the processor, a profitability metric for the patient;and generating a report corresponding to the profitability metric overtime.
 23. A computer-implemented method of providing a dosage and atransgender patient treatment life-cycle comprising: receiving, by acomputerized device comprising a processor, an input device, and adisplay screen, an input signal of a user indicating an input directedto a patient gender identity and a patient status, wherein the patientstatus is automatically determined by the processor and includes atleast one of a new patient, a returning patient and a booster patient;determining by the processor at least one of an effective estradioldosage and an effective testosterone dosage using a calculation methodselected based on the patient status, automated input parameters, andtracking parameters; determining, by the processor, an estradiol pelletsize insertion corresponding to the effective estradiol dosage and atestosterone pellet size insertion corresponding to the effectivetestosterone dosage using a pellet allocation algorithm, wherein aquantity of the estradiol pellet size insertion and the testosteronepellet size insertion are minimized; displaying, on the display screen,the determined effective dosages, the estradiol pellet size, and thetestosterone pellet size; and administering a pellet comprising at leastone of the determined effective dosages to the patient.
 24. The methodaccording to claim 23, further comprising: determining, by theprocessor, the effective estradiol dosage and the effective testosteronedosage if the patient gender identity is male-to-female; anddetermining, by the processor, the effective testosterone dosage if thepatient gender identity is female-to-male.
 25. The method according toclaim 23, wherein the automated input parameters comprise at least oneof a physical activity level, a quantity of patient visits, patient age,patient height, weight, race, number of pregnancies, number of livebirths, number of abortions, history of renal disease, history of activeliver disease, hysterectomy, history of cervical cancer, history ofovarian cancer, history of fibrocystic breast disease, history of breastcancer, current follicle stimulating hormone (FSH) level, currenttestosterone level, current estradiol level, history of acne, history offacial hair, history of hair loss, history of prostate cancer, historyof polycystic ovary syndrome (PCOS), history of hysterectomy, history ofheavy menses, history of metabolic syndrome, history of venousthrombotic events, history of estrogen-sensitive neoplasm, end-stagechronic liver disease, tobacco use, unstable coronary artery disease,untreated polycythemia, hematocrit level, cardiovascular disease,cerebrovascular disease, bone density, aggression development offeminine characteristics, and development of masculine characteristics.26. The method according to claim 25, further comprising automaticallycalculating, by the processor, at least one of the patient age based ona date of birth entered into the input device by the user and thepatient height based on a height parameter entered into the input deviceby the user.
 27. The method according to claim 25, wherein the dosagemethod for a male-to-female booster and return patient furthercomprises: receiving, by the processor, at least one of a level ofestradiol, a level of total testosterone, a level of free testosterone,and a level of prostate-specific antigen of the patient; anddetermining, by the processor, an estradiol dosage in response toreceiving the level of estradiol that is between approximately 200 and400 pg/ml; and determining, by the processor, an anti-androgen dosagebased on at least one of the level of total testosterone, the level offree testosterone, and the level of prostate-specific antigen.
 28. Themethod according to claim 25, wherein the dosage method for afemale-to-male booster and return patient further comprises: receivingby the processor at least one of a level of estradiol, a level of totalestrogens, a level of total testosterone, and a level of freetestosterone of the patient; determining, by the processor, atestosterone dosage in response to receiving an indication that thelevel of total testosterone is between approximately 600 and 800 ng/dl;and determining, by the processor, at least one of a letrozole dosageand an anastrozole dosage based on at least one of the level ofestradiol and the level of total estrogens.
 29. The method according toclaim 23, wherein using dosage calculation methods selected based on thetracking parameters includes tracking at least one of a pellet insertionlocation, a pellet insertion side, a pellet dose, a pellet lot number,an insertion note, a previous testosterone dose, and a previousestradiol dose.
 30. The method according to claim 29, further comprisingautomatically displaying at least one of the previous estradiol dose andthe previous testosterone dose on the display screen, wherein theprevious estradiol dose and the previous testosterone dose are based ona last full dosage, the last full dosage being different from at leastone previous effective dosage.
 31. The method according to claim 29,wherein tracking the pellet insertion location and the pellet insertionside is based on historical insertion information including at least oneof a hip location, an abdominal location, a left side, and a right side;and wherein, based on the historical insertion information, the pelletinsertion location and the pellet insertion side are automaticallysuggested by the processor.
 32. The method according to claim 29,wherein tracking the pellet lot number comprises entering acorresponding lot number into at least one lot number field provided onthe display screen of the input device.
 33. The method according toclaim 23, further comprising: ordering, by the processor, a plurality ofpellet sizes from largest to smallest; subtracting, by the processor, alargest of the plurality of pellet sizes from the effective dosage; andif a result of the subtraction is greater than zero, assigning thelargest of the plurality of pellet sizes as the estradiol pellet sizeinsertion or the testosterone pellet size insertion; if a result of thesubtraction is less than zero, subtracting a next smallest one of theplurality of pellet sizes from the effective dosage until the result isgreater than zero; and calculating an absolute value of the result ofthe subtraction that is less than zero and an absolute value of theresult of the subtraction that is greater than zero; and assigning, bythe processor, one of the plurality of pellet sizes as the estradiolpellet size insertion or the testosterone pellet size insertioncorresponding to the result having a lesser absolute value.
 34. Themethod according to claim 23, further comprising incorporating, by theprocessor at least one return visit associated with the patient todetermine at least one of the effective estradiol dosage and theeffective testosterone dosage.
 35. The method according to claim 23,further comprising providing a comprehensive toolkit on the inputdevice, the comprehensive toolkit kit comprising at least one of anancillary support function, a patient consult request, a patient consultresponse, an article, a video, a form, news, an update, a productpurchase order, a financial report, and an assistant assignment relatedto the dosage and patient treatment life-cycle.
 36. The method accordingto claim 23, further comprising: tracking, using the processor, aprofitability metric for the patient; and generating a reportcorresponding to the profitability metric over time.